Tags: genetic | tests | prenatal | abortion

Do New Genetic Tests Prompt More Abortions?

By    |   Monday, 15 Dec 2014 05:33 PM

A new generation of genetic screening tests has revolutionized prenatal testing in the past three years, with manufacturers promising to detect with near-perfect accuracy the risk a fetus may have a chromosomal abnormality, such as Down syndrome.

But a three-month analysis by the New England Center for Investigative Reporting has found that companies are overselling the accuracy of the tests and doing little to educate expecting parents or their doctors about the significant risks of false alarms. Some experts say the tests, taken by hundreds of thousands of women, may be prompting unnecessary abortions.
 
Sparked by the sequencing of the human genome a decade ago, the screening tests — including the so-called MaterniT21 — have taken the market by storm, but are not closely regulated, the NECIR found.
 
Two recent industry-funded studies show that test results indicating a fetus is at high risk for a chromosomal condition can be a false alarm half of the time. And the rate of false alarms goes up the more rare the condition, such as Trisomy 13, which almost always causes death.
 
Obstetricians at Boston Maternal Fetal Medicine submitted blood samples from two women who were not pregnant to five commercial labs that perform these new screens, claiming the samples were from women who were 12 weeks pregnant. The study was funded by Ariosa Diagnostics Inc., one of the testing companies.
 
Three of the labs returned results that indicated the presence of a normal female fetus, even though the samples were from non-pregnant women. The doctors who conducted the experiment said the findings underscore the need for better oversight of the screens, which are catching on rapidly in the U.S. and globally.
 
“Quality controls are zero,’’ said Tamara Takoudes, M.D., co-author of a letter to the editor describing the experiment, published online in the journal Ultrasound in Obstetrics & Gynecology. “As physicians we have to be more leery about the products we are using.”
 
The companies involved in the experiment were: Sequenom Inc., which offers the MaterniT21 PLUS screen; Illumina Inc., which offers verifi; and LabCorp, which uses the same sequencing technology as Illumina under the name informaSeq. Illumina and Sequenom both said the study was flawed because the screens are not designed to test for pregnancy. LabCorp did not return a request for comment.
 
The screens, known as non-invasive prenatal tests (NIPT), analyze placental DNA in a mother’s blood to pinpoint potential chromosomal conditions, such as Down syndrome.
Studies have shown NIPT to perform better than traditional screens.

But the U.S. Food and Drug Administration does not regulate the labs offering NIPT, although the agency recently announced plans to begin regulating a broad array of diagnostic tests that would include NIPT. The new rules, if approved, could take several years to implement.

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Health experts are raising questions about a new generation of genetic screening tests that has revolutionized prenatal testing for the risk a fetus may have a chromosomal abnormality, such as Down syndrome.
genetic, tests, prenatal, abortion
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2014-33-15
Monday, 15 Dec 2014 05:33 PM
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